Development Scientist

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is to one of Our clients who offer biotechnology product development services. The Company focuses on providing laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety, and education.

Job Title: Development Scientist

Duration: 12 Months

Work Location: San Jose CA 95134

Job Type: Contract

Work Type: Onsite

Job Description:

• This position is responsible to lead the hardware testing and validation efforts, particularly focused on LC/MS applications using the triple quadrupole-based instruments to ensure comprehensive testing in compliance with FDA and international regulatory standards.

Key Responsibilities Include:

• Be an integral member on project core teams as a representative of the Verification and Validation department.

• Operate within the Product Development Process and be familiar with the principles of working within a Quality Management System or regulated laboratories.

• Lead the verification and validation efforts for IVD products that are compliant with FDA, IVDR and other international regulatory standards.

• Write documentation, such as test plans, protocols, and reports.

• Maintain documents that records all aspects of experimental design and results, following good documentation practices.

• Independently perform experiments and generate data in support of product requirements.

• Responsible for accuracy and completeness of auditable documents.
  Support risk management activities as a technical subject matter expert (FMEA, Hazard Analysis, etc.)

• Work successfully with other departments- including but not limited to Manufacturing, Quality, Regulatory, and Marketing - for the development, transfer, submission, and commercialization of IVD products.

• Create and present formal Design Review presentations at key milestones.

Minimum Requirements/Qualifications:

• MS degree and 6+ years; PhD and 2+ years in Chemistry or relevant field (Biomedical engineering, Biochemistry, etc.).

• 5-10 years work experience (including advanced degree studies) with hands-on experience operating and maintaining LCMS with knowledge of method development, range of applications and software.

• Strong knowledge of both LC and MS instrumentation.

• Solid understanding in one or more of Proteomics, Lipidomics, Pharma/Biopharma, Clinical or Food & Environmental analytical industries.

• Experience with IVD products and working under design control

• Proven understanding of design control for regulated products (e.g. FDA, IVD, IVD-R, China and Japan regulations) and knowledge of applicable regulatory and quality standards used in product development process (e.g. ISO:13485 and 21 CFR 820)

• Good understanding of controlled documentation and data systems.

• Self-motivated and can work independently with minimal direction

• Demonstrated ability for high-quality results, technical proficiency, laboratory skills, collaboration with other departments.

• Ability to present and communicate (oral and written) information in a clear manner.

• Computer skills such as Word and Excel.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity